Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials

Angela Moore, Lawrence J. Green, Suzanne Bruce, Neil Sadick, Eduardo Tschen, Philip Werschler, Fran E. Cook-Bolden, Sunil S. Dhawan, Douglass Forsha, Michael H. Gold, Scott Guenthner, Steven E. Kempers, Leon H. Kircik, Jennifer L. Parish, Marta I. Rendon, Phoebe Rich, Linda Stein-Gold, Stephen K. Tyring, Robert A. Weiss, Adnan NasirCarsten Schmitz, Terry I. Boodhoo, Alexandre Kaoukhov, David R. Berk

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Abstract

BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

Original languageEnglish (US)
Pages (from-to)987-996
Number of pages10
JournalJournal of drugs in dermatology : JDD
Volume17
Issue number9
StatePublished - Sep 1 2018

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ASJC Scopus subject areas

  • Dermatology

Cite this

Moore, A., Green, L. J., Bruce, S., Sadick, N., Tschen, E., Werschler, P., Cook-Bolden, F. E., Dhawan, S. S., Forsha, D., Gold, M. H., Guenthner, S., Kempers, S. E., Kircik, L. H., Parish, J. L., Rendon, M. I., Rich, P., Stein-Gold, L., Tyring, S. K., Weiss, R. A., ... Berk, D. R. (2018). Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. Journal of drugs in dermatology : JDD, 17(9), 987-996.